STEEPLE研究课件（PPT 8页）.ppt

Safety and Efficacy of Intravenous Enoxaparin in Elective Percutaneous Coronary Intervention: an International Randomized Evaluation (STEEPLE) STEEPLE Trial: Primary Endpoint at 48 hours STEEPLE Trial: Primary Endpoint at 48 hours STEEPLE Trial Summary Among patients undergoing non-emergent PCI, treatment with reduced dose enoxaparin was associated with lower rates of major or minor bleeding by 48 hours post-PCI compared with treatment with ACT-driven UFH. Patient enrollment in the enoxaparin 0.5 mg/kg treatment group was discontinued by the data safety monitoring committee near the end of the trial at the objection of the steering committee, due to a difference in mortality between the three groups (p=0.02). With full 30 day data, neither mortality, MI, nor urgent target vessel revascularization differed between the three groups. Further investigation is still necessary, but the results from this trial show that the use of enoxaparin at lower doses in the catheterization laboratory may offer a potential safety advantage with lower bleeding events relative to ACT guided UFH. www. Clinical trial Presented at The European Society of Cardiology Hot Line Session 2005 Presented by Dr. Gilles Montalescot STEEPLE Trial IV enoxaparin 0.5 mg/kg n=1070 STEEPLE Trial Presented at ESC 2005 IV enoxaparin 0.75 mg/kg n=1228 3528 patients age 18 years undergoing non-emergent single or multi-vessel PCI (performed with a femoral approach) Randomized 25% female, mean age 64 years, mean follow-up 30 days GP IIb/IIIa inhibitors were used in 41% of patients, and aspirin in 85% Drug-eluting stents were used in 57% of patients and multivessel PCI was performed in 16% of patients Primary Endpoint: Non-CABG related major and minor bleeding by 48 hrs post-PCI Secondary Endpoint: Percent of patients reaching target anticoagulation levels at the start and end of the procedure; composite of non-CABG major bleed through 48 hrs; all-cause mortality; myocardial infarction; urgent target vessel re